INCLUSION CRITERIA:
Age equal to or greater than 30 years, male or female
Written informed consent
All ethnicities
Viral hepatitis status:
- Cases:
-- History of chronic hepatitis C defined by past positivity for serum HCV-RNA, HCV antibody and elevated serum alanine or aspartate aminotransferase levels for at least 6 months before start of treatment
-- Genotype 1, 2 or 3
-- Absence of detectable serum HCV-RNA by PCR on screening visit and on a previous test, at least 3 months apart. Both tests have to be performed at least 24 weeks after cessation of therapy
-- Past treatment with interferon alfa (standard or pegylated) for at least 12 weeks
-- At least 24 months after end of interferon treatment
-- Normal liver enzymes on screening visit
- Genotype 1 controls:
-- Detectable serum HCV-RNA on screening visit
-- Past treatment with interferon alfa (standard or pegylated) for at least 12 weeks
-- At least 24 months after end of interferon treatment
-- Age (difference less than or equal to 3 years), sex and race-matched with genotype 1 cases
- Genotype 2 and 3 controls:
-- Detectable serum HCV-RNA on screening visit
-- If previously treated with interferon alfa (standard or pegylated) - at least 24 months elapsed from the end of treatment
-- Age (difference less than or equal to 3 years), sex, race and genotype-matched with genotype 2 and 3 cases
EXCLUSION CRITERIA:
Pregnancy or lactation
History of clinical atherosclerotic disease manifest as:
- Ischemic cerebrovascular accident (CVA), transient ischemic accident (TIA) or radiological evidence of stroke.
- Proven coronary artery disease - history of myocardial infarction, need for coronary angioplasty or coronary artery bypass graft, anginal syndrome with confirmatory stress test or cardiac imaging.
- Symptomatic peripheral vascular disease, history of angioplasty or surgical bypass.
- History of carotid artery surgery or angioplasty
- Patients with overt atherosclerotic disease can be included if the first manifestation of that disease appeared at least 3 years after cessation of interferon treatment. Control patients who were never treated in the past will not be included if there is an overt manifestation of atherosclerosis.
Diabetes mellitus - unless fasting blood sugar can be maintained within normal limits and HBA1C less than 7 without the need for pharmacologic intervention
Hypertension - unless blood pressures can be maintained for greater than 6 months within normal limits without the need for pharmacologic intervention
Current treatment with cholesterol lowering medications
Chronic renal failure (creatinine clearance less than 50 ml)
Known HIV infection
HCV genotype 4, 5, 6 or mixed infection.
Other causes of liver disease apart from hepatitis C (hepatitis B, alcoholic liver disease, NASH, autoimmune hepatitis, PBC etc.). Bland, non-alcoholic hepatic steatosis will not constitute an exclusion criterion
History of trauma to the neck, surgery or deformity precluding sonographic visualization of the carotid arteries
Inability to sign or understand the informed consent form
A contraindication or unwillingness to undergo the coronary calcium score CT scan will not be an exclusion criterion, as this is not a primary end-point, as long as the participant is willing to undergo an IMT measurement.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/17/2008